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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Specimen Collection
510(k) Number K920536
Device Name AFFIRM VP SAMPLE COLLECTION SET
Applicant
Microprobe Corp.
1725 220th St., SE, 104
Bothell,  WA  98021
Applicant Contact MONICA A KRIEGER
Correspondent
Microprobe Corp.
1725 220th St., SE, 104
Bothell,  WA  98021
Correspondent Contact MONICA A KRIEGER
Regulation Number866.2900
Classification Product Code
LIO  
Date Received02/05/1992
Decision Date 07/30/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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